| 1.Research backgroundAt present,the incidence and mortality of malignant tumors are increasing year by year.Cancer is becoming the leading cause of death in China.The propaganda,prevention and treatment of cancer has also become an important public health problem in China.In the comprehensive treatment of tumor,chemotherapy is one of the main measures for the treatment of oncology.Because of the scope of application of paclitaxel and oxaliplatin chemotherapy is very extensive,and two drug induced peripheral neuropathy is common,therefore caused by chemotherapy of peripheral neuropathy(Chemotherapy-induced peripheral,neuropathy,CIPN)has become a problem in the face of many cancer patients,even suffering from the long-term impact on quality of life.The clinical treatment of CIPN needs to be solved,but the current research shows that western medicine has not been able to solve the effective measures of CIPN properly.2.Clinical research2.1 PurposeThrough this clinical study,the therapeutic effect of Shiweiyiyuan granules on peripheral neuropathy caused by chemotherapy was observed.This clinical trial provides a clinical basis for the treatment of peripheral neuropathy caused by chemotherapy with Shiweiyiyuan granules,and lays the foundation for the follow-up multicenter RCT clinical study.2.2 MethodThis study adopts self controlled observation method,Oral administration of Shiweiyiyuan granules,boiled water washed,once 12g,3 times a day,2 weeks for 1 courses,a total of 2 courses of treatment.Peripheral neuropathy grading,TNSc and TCM symptom scale were evaluated before treatment,2 weeks and 4 weeks respectively.The results of the experimental observation were all with the actual value as the parameters,the statistical calculation was carried out by the SPSS20.0 statistical analysis system.The measurement data met the normal distribution,and the t test was used.The classification data were tested with the Wilcoxon rank sum test.P<0.05 was statistically significant,P<0.001 had significant statistical significance.2.3 Result2.3.1 Peripheral neuropathy2.3.1.1 Analysis of the curative effect of peripheral neuropathyClassification of peripheral nerves before and after treatment:a total of 30 patients were included in this clinical study.As treatment progressively increased,grade 0 gradually increased and grade II gradually decreased.Analysis of the curative effect of peripheral neuropathy:after 2 weeks of treatment,the number of cured cases was 3,effective 0 cases,effective 8 cases,19 cases invalid,the total effective rate was 36.67%.After 4 weeks of treatment,the number of cured cases was 13,the effective 11 cases,invalid 6 cases,total effective 80%.Using Wilcoxon W test,there was a significant difference in the grading of curative effect in different treatment stages(P=0.000<0.05),which was comparable.Combined with total effective rate analysis,treatment for 4 weeks was better than 2 weeks.Prolonging treatment time is beneficial to improve the classification of peripheral neuropathy.2.3.1.2 Analysis of the effect of peripheral neuropathy at various levelsThe total effective rate of 2 weeks for grade ?,grade ? and grade ? peripheral neuropathy respectively was 21.42%,57.14%,0%.The total effective rate of grade ?,class ? and grade ? peripheral neuropathy was not statistically significant(P=2.47>0.05)after 2 weeks of treatment.In combination with the efficiency,Shiweiyiyuan granules had a therapeutic effect on the peripheral neuropathy of grade ? and grade ?in the 2 week treatment period,and the effective rate of grade ? was higher than that of grade I,but the grade ? was not effective.Although there is difference in the effective rate between grade ? and grade ? peripheral neuropathy,there is no statistical difference.The total effective rate of 4 weeks for grade I,grade II and grade III peripheral neuropathy respectively was 71.43%,92.86%,50%.The total effective rate of grade I,grade II and grade III peripheral neuropathy was not statistically different(P=0.153>0.05)after 4 weeks of treatment.In combination with the efficiency,Shiweiyiyiyuan granules had a curative effect on the peripheral neuropathy of grade I and grade II in the 4 week treatment period,the total effective rate was higher than that of the treatment 2 weeks,and the total effective rate of grade II was still higher than that of grade I,and the effective rate of grade III was 50%.Although there were differences in the total effective rate of grade I,grade II and grade III peripheral neuropathy,there was no statistical difference.2.3.2 Analysis of Total Neuropathy Score-clinical versionThe four quantiles of TNSc before treatment,2 weeks of treatment and 4 weeks of treatment were 6(4,10),4(2.75,7.25),2(0.75,3.25),P=0.000 respectively.Before treatment,2 weeks treatment of TNSc comparison,P=0.000<0.01,there were significant statistical differences;before treatment,4 weeks treatment of TNSc comparison,P=0.000<0.01,there were significant statistical differences;2 weeks of treatment,4 weeks of treatment of TNSc comparison,P = 0.001<0.01,there were significant statistical differences.TNSc showed a trend of continuous decline,indicating that Shiweiyiyuan granules could significantly improve the total.neuropathy score,improve the symptoms of peripheral neuropathy,and prolong the treatment cycle to improve the symptoms of peripheral neuropathy.2.3.3 Syndrome analysis of traditional Chinese Medicine2.33.1 Analysis of TCM SyndromeBefore treatment,2 weeks Of treatment and 4 weeks of treatment,the TCM syndrome scores of X±S respectively were 7.37±2.51,4.87±2.27,2.63±1.87,P<0.001,and there were significant differences between three groups.Before treatment and 2 weeks of treatment,TCM syndrome scores were compared,P=0.000<0.01,there were significant statistical differences.Before treatment and 4 weeks of treatment,TCM syndrome scores were compared,P=0.000<0.01,there were significant statistical differences;2 weeks of treatment and 4 weeks of treatment of TCM syndrome score compared,P=0.000<0.01,there were significant statistical differences.The score of TCM syndrome is declining continuously,which indicates that the Shiweiyiyuan granules have a significant role in improving the TCM syndrome of peripheral neuropathy,and there is a good persistence.2.3.3.2 Analysis of the efficiency of TCM SyndromeThe TCM symptoms 2 weeks of treatment efficiency was 60%,TCM symptoms 4 weeks of treatment efficiency was 100%,the value of =20.683,P<0.001,P values have significant difference.Shiweiyiyuan granules improves the TCM symptom of the patients,and prolong the treatment cycle to improve the symptoms of the TCM symptom.2.3.3.3 Comparison of pre-and post-scores of single symptomsThe P values of the symptoms of limbs numbness,limb distention and pain,cold and asthenia of cold limbs before treatment,treatment for 2 weeks,treatment for 2 weeks and 4 weeks,and 4 weeks before and after treatment were all less than 0.05,all of which were statistically different.The clinical symptoms of the peripheral neuropathy of the pishenkuixu type peripheral neuropathy in this clinical observation have a strong specificity,and Shiweiyiyuan granules have strong specificity for the treatment of the peripheral neuropathy of the pishenkuixu type,and the clinical symptoms of traditional Chinese medicine are obviously improved.2.3.4 Analysis of the difference between Shiweiyiyuan granules in treating OXAIPN and TIPN2.3.4.1 Analysis of the effect of peripheral neuropathyBefore treatment,there was no significant difference in the grading distribution of OXAIPN and TIPN in peripheral neuropathy(P=1>0.05),which could be used for follow-up analysis.After 4 weeks of treatment,the total effective rate of patients with peripheral neuropathy caused by OXAIPN was 93.33%,while the total effective rate of TIPN was 66.67%.Using Wilcoxon W test,there was a significant difference in the grading of peripheral neuropathy between the two groups(P=0.033<0.05).Combined with the total effective rate analysis,Shiweiyiyuan granule can significantly improve the classification of peripheral neuropathy of the two patients,but it can improve the grading of peripheral neuropathy of OXAIPN better.2.3.4.2 Analysis of the curative effect of TCM syndrome.Before treatment,there was no significant difference between OXAIPN and TIPN in TCM symptom score(P=0.138>0.05),which could be used for follow-up analysis.After 4 weeks of treatment,the total effective rate of patients with OXAIPN was 100%,while the total effective rate of TIPN was 100%.Using Wilcoxon W test,the curative effect of TCM syndromes in the two groups was statistically different(P=0.033<0.05).Combined with the total effective rate analysis,Shiweiyiyuan granules had significant improvement on TCM symptoms of OXAIPN and TIPN,but improved the TCM symptoms of OXAIPN.3.ConclusionShiweiyiyuan granule can significantly improve the peripheral neuropathy grading,TNSc,TCM symptom score,and its clinical effect is remarkable. |
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